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Efficacy and toxicity of Ipilimumab-Nivolumab combination therapy in elderly metastatic melanoma patients

INTRODUCTION: Immunotherapy has revolutionized metastatic Melanoma therapy. The most active regimen is combination therapy of Ipilimumab-Nivolumab (Ipi-Nivo) with response rates (RR) of ~60% and median overall survival (OS) of ~6 years. Immune-related adverse events (irAE) are common (~60% develop g...

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Autores principales: Stoff, Ronen, Grynberg, Shirly, Asher, Nethanel, Laks, Shachar, Steinberg, Yael, Schachter, Jacob, Shapira-Frommer, Ronnie, Ben-Betzalel, Guy
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Frontiers Media S.A. 2022
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9676931/
https://www.ncbi.nlm.nih.gov/pubmed/36419899
http://dx.doi.org/10.3389/fonc.2022.1020058
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author Stoff, Ronen
Grynberg, Shirly
Asher, Nethanel
Laks, Shachar
Steinberg, Yael
Schachter, Jacob
Shapira-Frommer, Ronnie
Ben-Betzalel, Guy
author_facet Stoff, Ronen
Grynberg, Shirly
Asher, Nethanel
Laks, Shachar
Steinberg, Yael
Schachter, Jacob
Shapira-Frommer, Ronnie
Ben-Betzalel, Guy
author_sort Stoff, Ronen
collection PubMed
description INTRODUCTION: Immunotherapy has revolutionized metastatic Melanoma therapy. The most active regimen is combination therapy of Ipilimumab-Nivolumab (Ipi-Nivo) with response rates (RR) of ~60% and median overall survival (OS) of ~6 years. Immune-related adverse events (irAE) are common (~60% develop grade 3-4) and pose a challenge when treating frail patients. We sought to examine whether Ipi-Nivo therapy is feasible in elderly metastatic melanoma patients. METHODS: Electronic records of patients treated at the Ella Lemelbaum Institute with Ipi-Nivo between the years 2017-2021 were screened for age. Elderly patients were defined as age 75 and older (group A) and were matched with records of patients age <75 (group B). Records were analyzed for baseline parameters, immunotherapy regimen, RR, toxicity and progression-free survival (PFS). RESULTS: Twenty-six relevant patients age >75 (median 77) were identified and were matched to 34 younger patients (median age 57). No statistically significant differences were noted in terms of baseline parameters except for BRAF mutation status (group A 15%, group B 47%, p=0.008). Response rate in group A was 38% and is consistent with previously published data. Median PFS was the same for both groups (A = 5.5 months, B= 7.5 months, p=NS). Treatment was similarly tolerated: 35% of group A patients completed 4 cycles of therapy compared to 28% for group B (p=NS). Grade 2-4 irAE were the same (A=58%, B=66%, p=NS) and there was no difference in the need for hospitalization for G3-4 events between the groups. (A=63%, B=69%, p=NS). Further division into 4 age groups (>80 vs 75-79 in group A and 65-74 vs <65 in group B) found no difference in terms of response rate or G3-4 toxicity. CONCLUSION: Ipilimumab-Nivolumab combination therapy in elderly metastatic Melanoma patients seems to be well tolerated and efficient in selected elderly patients based on performance status and comorbidities, just as in younger patients. This regimen seems to be a feasible treatment option for this age group.
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spelling pubmed-96769312022-11-22 Efficacy and toxicity of Ipilimumab-Nivolumab combination therapy in elderly metastatic melanoma patients Stoff, Ronen Grynberg, Shirly Asher, Nethanel Laks, Shachar Steinberg, Yael Schachter, Jacob Shapira-Frommer, Ronnie Ben-Betzalel, Guy Front Oncol Oncology INTRODUCTION: Immunotherapy has revolutionized metastatic Melanoma therapy. The most active regimen is combination therapy of Ipilimumab-Nivolumab (Ipi-Nivo) with response rates (RR) of ~60% and median overall survival (OS) of ~6 years. Immune-related adverse events (irAE) are common (~60% develop grade 3-4) and pose a challenge when treating frail patients. We sought to examine whether Ipi-Nivo therapy is feasible in elderly metastatic melanoma patients. METHODS: Electronic records of patients treated at the Ella Lemelbaum Institute with Ipi-Nivo between the years 2017-2021 were screened for age. Elderly patients were defined as age 75 and older (group A) and were matched with records of patients age <75 (group B). Records were analyzed for baseline parameters, immunotherapy regimen, RR, toxicity and progression-free survival (PFS). RESULTS: Twenty-six relevant patients age >75 (median 77) were identified and were matched to 34 younger patients (median age 57). No statistically significant differences were noted in terms of baseline parameters except for BRAF mutation status (group A 15%, group B 47%, p=0.008). Response rate in group A was 38% and is consistent with previously published data. Median PFS was the same for both groups (A = 5.5 months, B= 7.5 months, p=NS). Treatment was similarly tolerated: 35% of group A patients completed 4 cycles of therapy compared to 28% for group B (p=NS). Grade 2-4 irAE were the same (A=58%, B=66%, p=NS) and there was no difference in the need for hospitalization for G3-4 events between the groups. (A=63%, B=69%, p=NS). Further division into 4 age groups (>80 vs 75-79 in group A and 65-74 vs <65 in group B) found no difference in terms of response rate or G3-4 toxicity. CONCLUSION: Ipilimumab-Nivolumab combination therapy in elderly metastatic Melanoma patients seems to be well tolerated and efficient in selected elderly patients based on performance status and comorbidities, just as in younger patients. This regimen seems to be a feasible treatment option for this age group. Frontiers Media S.A. 2022-11-07 /pmc/articles/PMC9676931/ /pubmed/36419899 http://dx.doi.org/10.3389/fonc.2022.1020058 Text en Copyright © 2022 Stoff, Grynberg, Asher, Laks, Steinberg, Schachter, Shapira-Frommer and Ben-Betzalel https://creativecommons.org/licenses/by/4.0/This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) and the copyright owner(s) are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.
spellingShingle Oncology
Stoff, Ronen
Grynberg, Shirly
Asher, Nethanel
Laks, Shachar
Steinberg, Yael
Schachter, Jacob
Shapira-Frommer, Ronnie
Ben-Betzalel, Guy
Efficacy and toxicity of Ipilimumab-Nivolumab combination therapy in elderly metastatic melanoma patients
title Efficacy and toxicity of Ipilimumab-Nivolumab combination therapy in elderly metastatic melanoma patients
title_full Efficacy and toxicity of Ipilimumab-Nivolumab combination therapy in elderly metastatic melanoma patients
title_fullStr Efficacy and toxicity of Ipilimumab-Nivolumab combination therapy in elderly metastatic melanoma patients
title_full_unstemmed Efficacy and toxicity of Ipilimumab-Nivolumab combination therapy in elderly metastatic melanoma patients
title_short Efficacy and toxicity of Ipilimumab-Nivolumab combination therapy in elderly metastatic melanoma patients
title_sort efficacy and toxicity of ipilimumab-nivolumab combination therapy in elderly metastatic melanoma patients
topic Oncology
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9676931/
https://www.ncbi.nlm.nih.gov/pubmed/36419899
http://dx.doi.org/10.3389/fonc.2022.1020058
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